BC Week In Review | Jul 14, 2014
Clinical News

Clopidogrel/acetylsalicylic acid regulatory update

EMA’s CHMP recommended approval of clopidogrel/acetylsalicylic acid from Teva to prevent atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid. Specifically, the fixed-dose combination of the platelet aggregation inhibitors would be indicated...
BC Innovations | Nov 21, 2013
Targets & Mechanisms

Riding the integrin wave in thrombosis

The use of platelet integrin a 2b b 3 inhibitors in thrombosis, while clinically very effective, is associated with a high risk of bleeding that has limited their use. Now, researchers at the University of...
BioCentury | Jan 10, 2011

Buyside View XIX: Commercial Risk

Michael Flanagan Senior Writer  BioCentury's 19th Annual Buyside View finds money managers entering 2011 cautiously optimistic about biotech's prospects, particularly as some of the high-profile compounds have already reported some data, lowering risk. Amidst the...
BioCentury | Apr 5, 2010

1Q Approvals/1Q Setbacks

1Q Approvals/1Q Setbacks Selected first quarter product approvals Company Approval Acorda Therapeutics Inc. (NASDAQ:ACOR) FDA approves Ampyra dalfampridine (formerly Fampridine-SR) to improve walking ability in patients with multiple sclerosis (MS) Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) FDA...
BC Week In Review | Mar 29, 2010
Clinical News

DuoPlavin/ DuoCover clopidogrel/acetylsalicylic acid regulatory update

The European Commission approved an MAA from Bristol-Myers for DuoPlavin/DuoCover to prevent atherothrombotic events in adults already taking Plavix clopidogrel and acetylsalicylic acid. The product is a fixed-dose combination of Plavix and acetylsalicylic acid. Bristol-Myers...
BC Extra | Mar 25, 2010
Company News

EC approves DuoPlavin/DuoCover

The European Commission approved an MAA from Bristol-Myers Squibb Co. (NYSE:BMY) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY) for DuoPlavin / DuoCover to prevent atherothrombotic events in patients already taking Plavix clopidogrel and acetylsalicylic acid. DuoPlavin/DuoCover is...
BC Week In Review | Jan 4, 2010
Clinical News

DuoPlavin/DuoCover clopidogrel/acetylsalicylic acid regulatory update

EMEA's CHMP issued a positive opinion on an MAA from Bristol-Myers for DuoPlavin/DuoCover, a fixed-dose combination of clopidogrel and acetylsalicylic acid to prevent atherothrombotic events. Bristol-Myers and sanofi-aventis co-market Plavix clopidogrel, an adenosine diphosphate (ADP)...
BioCentury | Jan 12, 2009

2009 milestones

2009 milestones Selected products with Phase III or regulatory milestones expected in 2009. (A) The long-acting release formulation of Byetta exenatide uses Medisorb drug delivery technology from Alkermes (NASDAQ:ALKS); (B) Endo (NASDAQ:ENDP) is acquiring Indevus...
BioCentury | Jul 7, 2008

2Q approvals

2Q approvals Selected second quarter product approvals. The list does not include an FDA approvable letter for Zentase pancrealipase capsules to treat exocrine pancreatic insufficiency from Eurand (NASDAQ:EURX). While not a full approval, the company...
BC Week In Review | Jun 2, 2008
Clinical News

DuoPlavin clopidogrel/acetylsalicylic acid regulatory update

EMEA said Bristol-Myers and sanofi-aventis withdrew an MAA for DuoPlavin clopidogrel/acetylsalicylic acid to prevent atherothrombotic events in acute coronary syndrome (ACS) patients. The partners told the agency that they withdrew the application following a CHMP...
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